EPHEGREN - Longitudinal Pharmacoeconomical Study on Kidney Transplantation Patients
Head :
Marquet Pierre, INSERM UMR-S850 « Pharmacologie des immunosuppresseurs et de la transplantation »Service de pharmacologie, toxicologie et pharmacovigilance, CHU de Limoges
Marie Essig, INSERM UMR-S850 « Pharmacologie des immunosuppresseurs et de la transplantation »Service de pharmacologie, toxicologie et pharmacovigilance, CHU de Limoges
Marie Essig, INSERM UMR-S850 « Pharmacologie des immunosuppresseurs et de la transplantation »Service de pharmacologie, toxicologie et pharmacovigilance, CHU de Limoges
Last update : 09/07/2017 | Version : 2 | ID : 5209
| General | |
| Identification | |
| Detailed name | Longitudinal Pharmacoeconomical Study on Kidney Transplantation Patients |
| Sign or acronym | EPHEGREN |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL DR-2012-476 |
| General Aspects | |
| Medical area |
Urology, andrology and nephrology |
| Keywords | immunosuppressive strategies (IS), kidney transplants, assessment, impact, health insurance |
| Scientific investigator(s) (Contact) | |
| Name of the director | Marquet |
| Surname | Pierre |
| Address | 2 avenue Martin Luther King 87042 Limoges cedex |
| Phone | + 33 (0)5 55 05 60 17 |
| pierre.marquet@unilim.fr | |
| Unit | INSERM UMR-S850 « Pharmacologie des immunosuppresseurs et de la transplantation »Service de pharmacologie, toxicologie et pharmacovigilance, CHU de Limoges |
| Organization | CHU |
| Name of the director | Marie |
| Surname | Essig |
| Address | 2 avenue Martin Luther King 87042 Limoges cedex |
| Phone | + 33 (0)5 55 05 60 17 |
| marie.essig@inserm.fr | |
| Unit | INSERM UMR-S850 « Pharmacologie des immunosuppresseurs et de la transplantation »Service de pharmacologie, toxicologie et pharmacovigilance, CHU de Limoges |
| Organization | CHU |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | 2011 Interregional Hospital Clinical Research Programme (PHRC), Limoges University Hospital Centre (UHC). |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Limoges |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | 700 de novo renal transplant patients and 300 patients from a previous cohort of kidney transplant recipients |
| Database objective | |
| Main objective |
The main aim of the EPHEGREN study is to assess the pharmacoeconomic impact of different immunosuppressive strategies (IS) on kidney transplant patients from a hospital, health insurance and societal perspective.
The secondary objectives of the EPHEGREN study: To assess the cost-effectiveness of different preventative and curative strategies for reactivation and cytomegalovirus (CMV) disease in CMV+ kidney transplant patients (serologic status of recipient when receiving transplant) from a hospital, health insurance and societal perspective. To determine predictive pharmacological factors for long-term renal function outcome. To determine predictive pharmacological factors for the onset of cancer, diabetes and cardiovascular diseases. To validate the impact of genetic polymorphisms on metabolic enzymes, membrane transporters and proteins targeting immunosuppressants on exposure and the therapeutic and side effects of treatment. To prospectively validate urinary biomarker candidates for current or future acute rejection, or for chronic renal allograft dysfunction. |
| Inclusion criteria | Adult patients from both sexes during the first month of kidney transplantation who are able to complete the study questionnaire. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Pathology | Z94 - Transplanted organ and tissue status |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 6 hospitals (Limoges, Bordeaux, Toulouse, Rouen, Poitiers and Amiens). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2013 |
| Date of last collection (YYYY or MM/YYYY) | 2017 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 1,000 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Fluids (saliva, urine, amniotic fluid, …) |
| Details of biobank content | Other fluids (saliva, urine, amniotic fluid, etc.). |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation |
| Procedures | |
| Data collection method | In the patient medical file and from a patient questionnaire: on observance, adverse effects and quality of life, and socio-demographic datas |
| Classifications used | adverse events coded with MEDDRA |
| Quality procedure(s) used | eCRF developped with ENNOV CLINICA |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Details on monitoring of participants | 1, 3, 6, 12, 18, 24 months post-transplantation and then annually. |
| Followed pathology | Z94 - Transplanted organ and tissue status |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | DIM for medico-economic datas (PMSI) |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Conditions for access to the database is being defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
